83 FR 6199 - Request for Nominations on the National Mammography Quality Assurance Advisory Committee
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 30 (February 13, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 30 (February 13, 2018)
| Page Range | 6199-6200 | |
| FR Document | 2018-02922 |
[Federal Register Volume 83, Number 30 (Tuesday, February 13, 2018)] [Notices] [Pages 6199-6200] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02922] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-0417] Request for Nominations on the National Mammography Quality Assurance Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on the National Mammography Quality Assurance Advisory Committee in the Center for Devices and Radiological Health notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative to serve on the National Mammography Quality Assurance Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for an upcoming vacancy effective with this notice. DATES: Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests must send a letter stating that interest to FDA by March 15, 2018 (see sections I and II of this document for further details). Concurrently, nomination materials for prospective candidates should be sent to FDA by March 15, 2018. [[Page 6200]] ADDRESSES: All statements of interest from industry organizations interested in participating in the selection process of nonvoting industry representative nomination should be sent to Margaret Ames (see FOR FURTHER INFORMATION CONTACT). All nominations for a nonvoting industry representative should be submitted electronically by accessing the FDA Advisory Committee Membership Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002. Information about becoming a member of an FDA advisory committee can also be obtained by visiting FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm. FOR FURTHER INFORMATION CONTACT: Margaret Ames, Division of Workforce Management, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5264, Silver Spring, MD 20993, 301-796-5960, Fax: 301-847-8505, email: [email protected]. SUPPLEMENTARY INFORMATION: The Agency is requesting nominations for a nonvoting industry representative on the National Mammography Quality Assurance Advisory Committee: I. General Description of the Committee Duties The Committee shall advise FDA on: (1) Developing appropriate quality standards and regulations for mammography facilities; (2) developing appropriate standards and regulations for bodies accrediting mammography facilities under this program; (3) developing regulations with respect to sanctions; (4) developing procedures for monitoring compliance with standards; (5) establishing a mechanism to investigate consumer complaints; (6) reporting new developments concerning breast imaging that should be considered in the oversight of mammography facilities; (7) determining whether there exists a shortage of mammography facilities in rural and health professional shortage areas and determining the effects of personnel on access to the services of such facilities in these areas; (8) determining whether there will exist a sufficient number of medical physicists after October 1, 1999; and (9) determining the costs and benefits of compliance with these requirements. II. Selection Procedure Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests should send a letter stating that interest to the FDA contact (see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of this document (see DATES). Within the subsequent 30 days, FDA will send a letter to each organization that has expressed an interest, attaching a complete list of all such organizations; and a list of all nominees along with their current r[eacute]sum[eacute]s. The letter will also state that it is the responsibility of the interested organizations to confer with one another and to select a candidate, within 60 days after the receipt of the FDA letter, to serve as the nonvoting member to represent industry interests for the committee. The interested organizations are not bound by the list of nominees in selecting a candidate. However, if no individual is selected within 60 days, the Commissioner will select the nonvoting member to represent industry interests. III. Nomination Procedure Individuals may self-nominate and/or an organization may nominate one or more individuals to serve as a nonvoting industry representative. Nominations must include a current, complete r[eacute]sum[eacute] or curriculum vitae for each nominee and a signed copy of the Acknowledgement and Consent form available at the FDA Advisory Nomination Portal (see ADDRESSES). Nominations must also specify the advisory committee for which the nominee is recommended. Nominations must also acknowledge that the nominee is aware of the nomination unless self-nominated. FDA will forward all nominations to the organizations expressing interest in participating in the selection process for the committee. (Persons who nominate themselves as nonvoting industry representatives will not participate in the selection process.) FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and therefore encourages nominations of appropriately qualified candidates from these groups. Specifically, in this document, nominations for a nonvoting representative of industry interests are encouraged from the mammography manufacturing industry. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: February 7, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-02922 Filed 2-12-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Notices 6199
I. Background approval of FARYDAK represented the investigation, and must certify that a
The Drug Price Competition and first permitted commercial marketing or true and complete copy of the petition
Patent Term Restoration Act of 1984 use of the product. Thereafter, the has been served upon the patent
(Pub. L. 98–417) and the Generic USPTO requested that FDA determine applicant. (See H. Rept. 857, part 1, 98th
Animal Drug and Patent Term the product’s regulatory review period. Cong., 2d sess., pp. 41–42, 1984.)
Restoration Act (Pub. L. 100–670) II. Determination of Regulatory Review Petitions should be in the format
generally provide that a patent may be Period specified in 21 CFR 10.30.
extended for a period of up to 5 years Submit petitions electronically to
FDA has determined that the https://www.regulations.gov at Docket
so long as the patented item (human applicable regulatory review period for
drug product, animal drug product, No. FDA–2013–S–0610. Submit written
FARYDAK is 4,334 days. Of this time, petitions (two copies are required) to the
medical device, food additive, or color 3,997 days occurred during the testing
additive) was subject to regulatory Dockets Management Staff (HFA–305),
phase of the regulatory review period, Food and Drug Administration, 5630
review by FDA before the item was while 337 days occurred during the
marketed. Under these acts, a product’s Fishers Lane, Rm. 1061, Rockville, MD
approval phase. These periods of time 20852.
regulatory review period forms the basis were derived from the following dates:
for determining the amount of extension 1. The date an exemption under Dated: February 6, 2018.
an applicant may receive. section 505(i) of the Federal Food, Drug, Leslie Kux,
A regulatory review period consists of and Cosmetic Act (the FD&C Act) (21 Associate Commissioner for Policy.
two periods of time: A testing phase and U.S.C. 355(i)) became effective: April [FR Doc. 2018–02868 Filed 2–12–18; 8:45 am]
an approval phase. For human drug 15, 2003. The applicant claims April 15, BILLING CODE 4164–01–P
products, the testing phase begins when 2002, as the date the investigational new
the exemption to permit the clinical drug application (IND) became effective.
investigations of the drug becomes However, FDA records indicate that the DEPARTMENT OF HEALTH AND
effective and runs until the approval IND effective date was April 15, 2003, HUMAN SERVICES
phase begins. The approval phase starts which was the first date after receipt of
with the initial submission of an the IND that the investigational studies Food and Drug Administration
application to market the human drug were allowed to proceed.
product and continues until FDA grants 2. The date the application was [Docket No. FDA–2018–N–0417]
permission to market the drug product. initially submitted with respect to the
Although only a portion of a regulatory human drug product under section Request for Nominations on the
review period may count toward the 505(b) of the FD&C Act: March 24, 2014. National Mammography Quality
actual amount of extension that the FDA has verified the applicant’s claim Assurance Advisory Committee
Director of USPTO may award (for that the new drug application (NDA) for
example, half the testing phase must be AGENCY: Food and Drug Administration,
FARYDAK (NDA 205353) was initially HHS.
subtracted as well as any time that may submitted on March 24, 2014.
have occurred before the patent was 3. The date the application was ACTION: Notice.
issued), FDA’s determination of the approved: February 23, 2015. FDA has SUMMARY: The Food and Drug
length of a regulatory review period for verified the applicant’s claim that NDA Administration (FDA) is requesting that
a human drug product will include all 205353 was approved on February 23, any industry organizations interested in
of the testing phase and approval phase 2015. participating in the selection of
as specified in 35 U.S.C. 156(g)(1)(B). This determination of the regulatory
FDA has approved for marketing the nonvoting industry representatives to
review period establishes the maximum serve on the National Mammography
human drug product FARYDAK potential length of a patent extension.
(panobinostat). FARYDAK, in Quality Assurance Advisory Committee
However, the USPTO applies several in the Center for Devices and
combination with bortezomib and statutory limitations in its calculations
dexamethasone, is indicated for the Radiological Health notify FDA in
of the actual period for patent extension. writing. FDA is also requesting
treatment of patients with multiple In its applications for patent extension,
myeloma who have received at least 2 nominations for a nonvoting industry
this applicant seeks 1,751 days or 5 representative to serve on the National
prior regimens, including bortezomib years of patent term extension.
and an immunomodulatory agent. This Mammography Quality Assurance
indication is approved under III. Petitions Advisory Committee. A nominee may
accelerated approval based on Anyone with knowledge that any of either be self-nominated or nominated
progression free survival. Continued the dates as published are incorrect may by an organization to serve as a
approval for this indication may be submit either electronic or written nonvoting industry representative.
contingent upon verification and comments and, under 21 CFR 60.24, ask Nominations will be accepted for an
description of clinical benefit in for a redetermination (see DATES). upcoming vacancy effective with this
confirmatory trials. Subsequent to this Furthermore, as specified in § 60.30 (21 notice.
approval, the USPTO received patent CFR 60.30), any interested person may DATES: Any industry organization
term restoration applications for petition FDA for a determination interested in participating in the
FARYDAK (U.S. Patent Nos. 6,552,065; regarding whether the applicant for selection of an appropriate nonvoting
6,833,384; and 7,067,551) from Novartis extension acted with due diligence member to represent industry interests
sradovich on DSK3GMQ082PROD with NOTICES
AG, and the USPTO requested FDA’s during the regulatory review period. To must send a letter stating that interest to
assistance in determining the patents’ meet its burden, the petition must FDA by March 15, 2018 (see sections I
eligibility for patent term restoration. In comply with all the requirements of and II of this document for further
a letter dated October 15, 2015, FDA § 60.30, including but not limited to: details). Concurrently, nomination
advised the USPTO that this human Must be timely (see DATES), must be materials for prospective candidates
drug product had undergone a filed in accordance with § 10.20, must should be sent to FDA by March 15,
regulatory review period and that the contain sufficient facts to merit an FDA 2018.
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![6200 Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Notices
ADDRESSES: All statements of interest II. Selection Procedure U.S.C. app. 2) and 21 CFR part 14,
from industry organizations interested relating to advisory committees.
in participating in the selection process Any industry organization interested
in participating in the selection of an Dated: February 7, 2018.
of nonvoting industry representative
nomination should be sent to Margaret appropriate nonvoting member to Leslie Kux,
Ames (see FOR FURTHER INFORMATION represent industry interests should send Associate Commissioner for Policy.
CONTACT). All nominations for a
a letter stating that interest to the FDA [FR Doc. 2018–02922 Filed 2–12–18; 8:45 am]
nonvoting industry representative contact (see FOR FURTHER INFORMATION BILLING CODE 4164–01–P
should be submitted electronically by CONTACT) within 30 days of publication
accessing the FDA Advisory Committee of this document (see DATES). Within the
Membership Nomination Portal: https:// subsequent 30 days, FDA will send a DEPARTMENT OF HEALTH AND
www.accessdata.fda.gov/scripts/ letter to each organization that has HUMAN SERVICES
FACTRSPortal/FACTRS/index.cfm or by expressed an interest, attaching a
mail to Advisory Committee Oversight complete list of all such organizations; Food and Drug Administration
and Management Staff, Food and Drug and a list of all nominees along with
Administration, 10903 New Hampshire their current résumés. The letter will [Docket No. FDA–2016–N–0002]
Ave., Bldg. 32, Rm. 5103, Silver Spring, also state that it is the responsibility of
MD 20993–0002. Information about the interested organizations to confer Hospira, Inc. et al.; Withdrawal of
becoming a member of an FDA advisory with one another and to select a Approval of 44 New Drug Applications
committee can also be obtained by candidate, within 60 days after the and 158 Abbreviated New Drug
visiting FDA’s website at https:// receipt of the FDA letter, to serve as the Applications; Correction
www.fda.gov/AdvisoryCommittees/ nonvoting member to represent industry
default.htm. interests for the committee. The AGENCY: Food and Drug Administration,
interested organizations are not bound HHS.
FOR FURTHER INFORMATION CONTACT: by the list of nominees in selecting a
Margaret Ames, Division of Workforce candidate. However, if no individual is ACTION: Notice; correction.
Management, Center for Devices and selected within 60 days, the
Radiological Health, Food and Drug Commissioner will select the nonvoting SUMMARY: The Food and Drug
Administration, 10903 New Hampshire member to represent industry interests. Administration (FDA) is correcting a
Ave., Bldg. 66, Rm. 5264, Silver Spring, notice that appeared in the Federal
MD 20993, 301–796–5960, Fax: 301– III. Nomination Procedure Register of October 4, 2016 (81 FR
847–8505, email: margaret.ames@ Individuals may self-nominate and/or 68427). The document announced the
fda.hhs.gov. an organization may nominate one or withdrawal of approval of 44 new drug
more individuals to serve as a nonvoting applications and 158 abbreviated new
SUPPLEMENTARY INFORMATION: The drug applications (ANDAs) from
Agency is requesting nominations for a industry representative. Nominations
must include a current, complete multiple applicants, effective November
nonvoting industry representative on 3, 2016. The document erroneously
the National Mammography Quality résumé or curriculum vitae for each
nominee and a signed copy of the included abbreviated new drug
Assurance Advisory Committee: application (ANDA) 075726 for
Acknowledgement and Consent form
I. General Description of the Committee available at the FDA Advisory Pemoline Tablets, 18.75 milligrams
Duties Nomination Portal (see ADDRESSES). (mg), 37.5 mg, and 75 mg, held by
Nominations must also specify the Mallinkrodt Pharmaceuticals, LLC. This
The Committee shall advise FDA on: notice corrects that error.
(1) Developing appropriate quality advisory committee for which the
standards and regulations for nominee is recommended. Nominations FOR FURTHER INFORMATION CONTACT:
mammography facilities; (2) developing must also acknowledge that the Florine Purdie, Center for Drug
appropriate standards and regulations nominee is aware of the nomination Evaluation and Research, Food and
for bodies accrediting mammography unless self-nominated. FDA will Drug Administration, 10903 New
facilities under this program; (3) forward all nominations to the Hampshire Ave., Bldg. 51, Rm. 6248,
developing regulations with respect to organizations expressing interest in Silver Spring, MD 20993–0002, 301–
sanctions; (4) developing procedures for participating in the selection process for 796–3601.
monitoring compliance with standards; the committee. (Persons who nominate
themselves as nonvoting industry SUPPLEMENTARY INFORMATION: In the
(5) establishing a mechanism to Federal Register of Tuesday, October 4,
investigate consumer complaints; (6) representatives will not participate in
the selection process.) 2016, appearing on page 68427 in FR
reporting new developments concerning Doc. 2016–23893, the following
breast imaging that should be FDA seeks to include the views of
women and men, members of all racial correction is made:
considered in the oversight of
mammography facilities; (7) and ethnic groups, and individuals with 1. On page 68430, in table 1, the entry
determining whether there exists a and without disabilities on its advisory for ANDA 075726 is removed.
shortage of mammography facilities in committees and therefore encourages In a separate notice published in this
rural and health professional shortage nominations of appropriately qualified issue of the Federal Register, FDA is
areas and determining the effects of candidates from these groups. withdrawing the approval of ANDA
sradovich on DSK3GMQ082PROD with NOTICES
personnel on access to the services of Specifically, in this document, 075726 under 21 CFR 314.150(d).
such facilities in these areas; (8) nominations for a nonvoting
Dated: February 8, 2018.
determining whether there will exist a representative of industry interests are
encouraged from the mammography Leslie Kux,
sufficient number of medical physicists
after October 1, 1999; and (9) manufacturing industry. Associate Commissioner for Policy.
determining the costs and benefits of This notice is issued under the [FR Doc. 2018–02926 Filed 2–12–18; 8:45 am]
compliance with these requirements. Federal Advisory Committee Act (5 BILLING CODE 4164–01–P
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Document Created: 2018-02-13 02:32:36
Document Modified: 2018-02-13 02:32:36
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests must send a letter stating that interest to FDA by March 15, 2018 (see sections I and II of this document for further details). Concurrently, nomination materials for prospective candidates should be sent to FDA by March 15, 2018. | |
| Contact | Margaret Ames, Division of Workforce Management, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5264, Silver Spring, MD 20993, 301-796-5960, Fax: 301-847-8505, email: [email protected] | |
| FR Citation | 83 FR 6199 |
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